what is pec in compounding

by Mr. Davin Mann Published 3 years ago Updated 2 years ago

The primary engineering control or PEC (hood) is to be cleaned daily. The most common PECs used are laminar airflow workbenches (LAFWs), compounding aseptic isolators (CAIs), biological safety cabinets (BSCs), and compounding aseptic containment isolators (CACIs).

What is primary engineering control (PEC)?

Feb 03, 2020 · What is pec in compounding? The primary engineering control or PEC (hood) is to be cleaned daily. The most common PECs used are laminar airflow workbenches (LAFWs), compounding aseptic isolators (CAIs), biological safety cabinets (BSCs), and compounding aseptic containment isolators (CACIs).

What is the compounding environment of a primary engineering control?

Compounding PEC abbreviation meaning defined here. What does PEC stand for in Compounding? Get the top PEC abbreviation related to Compounding.

What is an ISO Class 5 PEC?

Primary engineering control (PEC): A system that provides an ISO 5 environment for the exposure of critical sites when com- pounding sterile preparations. Primary engineering control work surfaces, counters, floors and work surfaces in the buffer zone area, ante room and segregated compounding areas daily.

How often do you have to clean a PEC?

A-Z. Short first. Long first. PEC Pharmacy Abbreviation. 2. PEC. Primary Engineering Control. Compounding, Sterile, Medical. Compounding, Sterile, Medical.

What does PEC stand for compounding?

Compounding Aseptic Containment Isolator (CACI) Clean Area or Clean Zone. C-PEC (Primary Engineering Control)Apr 24, 2018

What is PEC primary engineering control?

Primary engineering control (PEC): A system that provides an ISO 5 environment for the exposure of critical sites when com- pounding sterile preparations. Primary engineering control work surfaces, counters, floors and work surfaces in the buffer zone area, ante room and segregated compounding areas daily.

What PECs may HDs be compounded in?

*All C-PECs used for manipulation of sterile HDs must be externally vented. Sterile HD compounding must be performed in a C-PEC that provides Class 5 or better air quality, such as a Class II or III BSC, or CACI. Class II BSC types A2, B1 or B2 are all acceptable.

What is a compounding aseptic containment isolator?

Compounding Aseptic Containment Isolator (CACI) provides a safe and clean environment for compounding of hazardous, sterile drug preparations in compliance with USP 797 and 800 criteria. It is suitable for work involving hazardous materials, antineoplastic, or cytotoxic compounding applications.

What is ISO Class 5 Pec?

To certify as ISO Class 5 the PEC will not have more than 3520 particles per cubic meter of air. This test must also be performed under dynamic conditions to show that the ISO Class 5 environment is maintained when compounding. Depending on the type of PEC other tests might be performed.

What ISO Class is the PEC room?

ISO 5

Every PEC is designed to maintain a certain level of cleanliness as defined by the United States Pharmacopeia (USP) and ISO 14644-1. By USP <797> definition, a PEC is a device or room that will maintain an ISO 5 environment.

Why is USP 800 necessary?

USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.

What is the USP 797?

USP 797 is the standard in place governing the sterile preparation of compounded pharmaceuticals. USP 797 covers the compounding of both hazardous and nonhazardous drugs with a focus on the protection of sterile compounds and environments from contamination.Jan 18, 2019

What is the difference between USP 797 and USP 800?

USP 797 provides standards for compounding of sterile preparations while USP 800 provides standards for the safe handling of HDs to minimize exposure risks. USP 797 promotes the protection of the sterility of the drug, while USP 800 is focused on the safety of personnel who come in contact with the HDs.Jul 23, 2019

What is the difference between CAI and CACI?

When working with non-hazardous material, a compounding aseptic isolator (CAI) is used to create a positive pressure controlled environment. When handling hazardous material, a compounding aseptic containment isolator (CACI) is used to create a negative pressure controlled environment.

What is isolator in pharmaceutical industry?

Pharmaceutical Isolator. An isolator is an arrangement of physical barriers that are integrated to the extent that the isolator can be sealed in order to carry out a routine leak test based on pressure to meet specified limits. Internally it provides a workspace, which is separated from the surrounding environment.Sep 25, 2007

What are the USP 800 standards in place for hazardous drugs?

For example, USP 800 calls for “personnel who transport, compound, or administer hazardous drugs to document their training according to OSHA standards (see OSHA Standard 1910.120 Hazardous Waste Operations and Emergency Response) and other applicable laws and regulations.” Stericycle can help keep your organization ...Nov 2, 2020

Examples of Primary engineering control in a sentence

Primary engineering control (PEC): A system that provides an ISO 5 environment for the exposure of critical sites when com- pounding sterile preparations.

More Definitions of Primary engineering control

Primary engineering control. ( PEC) means a device or room that provides an ISO Class 5 environment for the exposure of Critical Sites when compounding sterile products.

What is total particle count?

Total particle count testing must occur in the BSC during dynamic compounding conditions or with simulated compounding activities that are representative of the actual compounding activities. By requiring dynamic conditions, the testing ensures that the BSC is maintaining the desired classification and state of control during operations. As such, the dynamic conditions must be conducted by pharmacy personnel, not the certification technician.

What is a BSC in pharmacy?

Biological Safety Cabinets. The purpose of a biological safety cabinet (BSC) is to provide product, personnel, and environmental protection. In the pharmacy, BSCs are typically used for sterile compounding of hazardous drugs.

What is smoke pattern test?

An airflow smoke patterns test is required and must be performed at each certification. Do not mistake this test for a dynamic airflow smoke pattern test, as this test is not meant to demonstrate that first air is supplied to the DCA. Rather, the airflow smoke patterns test consists of four separate tests wherein smoke is utilized to visualize the airflow to ensure proper performance: 1 The Downflow Test determines whether airflow within the work area is downward with no dead spots or refluxing. 2 The View Screen Retention Test determines if there is any escape of air to the outside of the cabinet at the work opening. 3 The Work Opening Edge Retention Test determines if there is any ambient air that enters the cabinet and passes along the work surface. 4 The Sash Seal Test determines if there is any escape of air to the outside of the cabinet through the sides and top of the sash.

What is a laminar airflow workstation?

A laminar airflow workstation (LAFW) is used to provide product protection through unidirectional HEPA filtered air in the work zone. The following tests are required for certification, and the associated data must be documented:

Do you need calibration certificates for equipment?

Nonetheless, it is critical that calibration certificates be included with the final report for each piece of certification equipment that requires calibration. This ensures that the equipment used to perform testing is operating within its tolerated calibration interval. Ultimately, calibration documentation provides the evidence needed to establish the credibility of the report’s findings.

What is site assessment test?

Site installation assessment tests are performed during each BSC certification to ensure that the cabinet is integrated properly into the facility and that the alarm functions are operating as intended. The specific tests will depend upon the type of cabinet and whether the cabinet is ducted. Note that for HD applications, USP <800> requires that the cabinets be externally vented; however, if the cabinet is used for non-HD applications and is not externally vented, then not all tests apply. The sash alarm test does apply to all cabinets: When the sash is raised 1” above the manufacturer’s recommended height, an audible and visual alarm must sound. If the cabinet is newer than 2014 and NSF listed, there will also be a requirement to test the sash at 1” below the manufacturer’s recommended height. The sash alarm test and statement of pass or fail must be reported.

Proposed standards for allergen extract compounding under USP Chapter 797

Under the proposed standards, to continue in-office compounding of individual treatment sets for allergen immunotherapy, allergy practices will need to comply with the following:

2. Facilities

Compounding must occur in an ISO Class 5 PEC or in a dedicated Allergenic Extracts Compounding Area (AECA), either of which must not be within one meter from a sink and can’t be near unsealed windows, doors to the outside, or high traffic or other areas that present environmental control challenges such as bathrooms or kitchens.

3. Documentation

All facilities where allergen extracts are prepared must have and maintain written or electronic documentation to demonstrate compliance with the requirements USP Chapter 797. This documentation must include, but is not limited to, the following:

What is the purpose of personal protective equipment?

Use of personal protective equipment (PPE) Purpose: To provide employees protection from hazardous aerosols and drug residue during preparation of products. Sites must have a policy identifying appropriate PPE to be worn . Includes gloves and gowns.

What is PPE gown?

Use of personal protective equipment (PPE) Gowns. Gowns must be worn when handling HDs . Gowns must be able to protect worker from spills/splashes of HD and waste materials. These gowns must have been tested to resist permeability by HDs .

Where should antineoplastics be stored?

Antineoplastics requiring manipulation and HD APIs must be stored separately from non-hazardous drugs and should be stored in an externally ventilated, negative pressure room with at least 12 air pressure changes per hour (ACPH). Ordering, Receiving, and Stocking Hazardous Drugs.

What should I wear to unpack HDs?

Personnel who unpack HDs that are not contained in plastic should wear an elastomeric half-mask with a multi-gas cartridge and P100 filter. PAPR should be worn when there is a risk of respiratory exposure to HDs, including: An HD spill that cannot be contained to a spill kit.

What is HD in medical terms?

Containment, clean up, and disposal procedures . Treatment of personal contact and any unintended exposure to a HD. Overview. Hazardous drugs (HD) are drugs that can cause adverse health effects if health care workers that handle (including distribution, preparation, or administration) these products are exposed to them.